1. Technical Field
The preferred embodiments described herein relate generally to devices for delivering a medical interventional device for repair of body structures that define body lumens. More particularly, they relate to delivery devices for delivering expandable prostheses and like devices for repairing damaged body structures and gaining hemostasis or fluid stability during emergency open surgical medical procedures.
2. Background Information
Trauma physicians frequently encounter patients having traumatic injury to a body vessel, such as lacerated vessels or even transected vessels, resulting from gunshots, knife wounds, motor vehicle accidents, explosions, etc. Significant damage to a body vessel may expose a patient to deleterious conditions such as the loss of a limb, loss of function of a limb, increased risk of stroke, impairment of neurological functions, and compartment syndrome, among others. Particularly severe cases of vascular injury and blood loss may even result in death. In such severe situations, the immediate goal is to obtain hemostasis while maintaining perfusion of adequate blood flow to critical organs, such as the brain, liver, kidneys, and heart.
Examples of treatment that are commonly performed by trauma physicians to treat body vessel injuries include the clamping of the vessel with a hemostat, the use of a balloon tamponade, the ligation of the damaged vessel at or near the site of injury, and/or the insertion of one or more temporary shunts. However, conventional surgical repair is generally difficult with actively bleeding, moribund patients. In many instances, there is not enough time to repair the body vessel adequately by re-approximating and suturing the body vessel. Thus, the trauma physician may simply insert a temporary shunt into the vessel. However, use of temporary shunts has been linked to the formation of clots. This may require returning the patient to the operating room for treatment and removal of the clots, often within about 36 to 48 hours of the original repair. Since such shunts are generally placed as a temporary measure to restore blood flow and stop excessive blood loss, the shunt is typically removed by a specialized vascular surgeon once the patient has stabilized (generally a few days later). After removal, the vascular surgeon will typically replace the shunt with a vascular graft, such as a fabric graft that is sewn into place. With respect to ligation, ligation of the damaged blood vessel may result in muscle necrosis, loss of muscle function, or a potential limb loss or death.
Due to the nature of the body vessel injury that may be encountered, the insertion of shunts or ligation of a blood vessel, for example, often requires that such treatments be performed within a very short period of time. Such treatments may occupy an undue amount of time and attention of the trauma physician at a time when other pressing issues regarding the patient's treatment require immediate attention. In addition, the level of particularized skill required to address a vascular trauma and stabilize the patient may exceed that possessed by the typical trauma physician.
Some open surgical techniques utilize sutures to affix damaged tissue portions to fittings that have been deployed with the vessel. Such techniques require the trauma physician to take sufficient time to tie the sutures properly. Even though in modern medicine sutures can be tied in relatively rapid fashion, any step in a repair process that occupies physician time in an emergency situation is potentially problematic. In addition, the use of sutures to affix the vessel to the fitting compresses the tissue of the vessel against the fitting. Compression of tissue may increase the risk of necrosis of the portion of the vessel tissue on the side of the suture remote from the blood supply. When present, necrosis of this portion of the vessel tissue may result in tissue separation at the point of the sutures. In this event, the connection between the vessel and the fitting may eventually become weakened and subject to failure. If the connection fails, the device may disengage from the vessel. Therefore, efforts continue to be made to develop suitable techniques that reduce the physician time required for such repair, so that this time can be spent on other potentially life-saving measures, and so that the blood flow may be more quickly restored and any resulting damage caused by lack of blood flow is minimized.
What is needed is a device for delivering a prosthesis for repair of a damaged body vessel, such as an artery or a vein, (and in particular a transected vessel) during emergency open surgery. It would be desirable if the delivery device was easy for a trauma physician to use, and was useful for the rapid introduction of a prosthesis into a body vessel, thereby providing a conduit for blood or fluid within the damaged body vessel.